FDA.reportPublic FDA data

Blue Lizard Active SPF 50 Sunscreen

Manufacturer
Crown Laboratories
Effective date
2024-11-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:48:39

Label at a glance#

ProductBlue Lizard Active SPF 50 Sunscreen
Active ingredientOCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn and photodamage caused by UVA/UVB exposure Higher SPF gives more sunburn protection If used as directed with other sun protection measures (see Directions ), decreases the risks of skin cancer and early skin aging caused by the sun

Dosage and administration

• Shake well prior to use • Apply liberally to dry skin 15 minutes before sun exposure • For topical use only • Children under 6 months: ask a doctor • Sun Protection Measures : Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in t...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octisalate 5%

Titanium Dioxide 5.36%

Zinc Oxide 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn and photodamage caused by UVA/UVB exposure
  • Higher SPF gives more sunburn protection
  • If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

• When using this product • Keep out of eyes. Rinse with water to remove

• Stop use and ask doctor if • Rash or irritation occurs

• Do not use • On damaged or broken skin • If allergic to any ingredient

• If swallowed, get medical help or contact a Poison Control Center

Directions

DOSAGE & ADMINISTRATION SECTION

• Shake well prior to use

• Apply liberally to dry skin 15 minutes before sun exposure

• For topical use only

• Children under 6 months: ask a doctor

• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m.

• Wear long-sleeved shirts, pants, hats, and sunglasses.

• Reapply to dry skin: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Other Information

OTHER SAFETY INFORMATION

  • Protect the product in this container from excessive heat and direct sun
  • May stain some fabrics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alumina, Aluminum Stearate, Beeswax, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Capylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Diisopropyl Sebacate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Hexyl Laurate, Hydrogenated Castor Oil, Isostearyl Isostearate, L-Arginine, Methyl Glucose Dioleate, Methylpropanediol, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Phenylpropanol, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polyurethane-35, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer

Questions?

OTC - QUESTIONS SECTION

Visit www.bluelizardsunscreen.com or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

RECENT MAJOR CHANGES SECTION

Formatted Uses section

Formatted Directions section

Blue Lizard Active 5oz Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BLUE LIZARD

AUSTRALIAN SUNSCREEN

50+

UVA/UVB PROTECTION

BROAD SPECTRUM

SPF 50+

TRAUSTED BY DERMATOLOGISTS FOR OVER 20 YEARS

ACTIVE

mineral-based sunscreen

combining mineral and chemical UV protectors

Smart Cap TECHNOLOGY

CAP CHANGES COLOR IN HARMFUL UV LIGHT

WATER RESISTANT (80 MINUTES)

Mineral-Based Sunscreen

Combining mineral and chemical UV protectors for water-resistant performance you can trust.

P11863.00

5oz-tube5oz-tube

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0316-2072-302023-02-13C16284748780-1f386c64a-46d1-0266-e053-dadaa90a7c1aBlue Lizard Active SPF 50 Sunscreen
0316-2072-402023-02-13C16284748780-1f386c64a-46d1-0266-e053-dadaa90a7c1aBlue Lizard Active SPF 50 Sunscreen
0316-2072-452023-02-13C16284748780-1f386c64a-46d1-0266-e053-dadaa90a7c1aBlue Lizard Active SPF 50 Sunscreen
0316-2072-502023-02-13C16284748780-1f386c64a-46d1-0266-e053-dadaa90a7c1aBlue Lizard Active SPF 50 Sunscreen
0316-2072-302023-01-30C16284748780-1f386c64a-46d1-0266-e053-dadaa90a7c1aBlue Lizard Active SPF 50 Sunscreen
0316-2072-402023-01-30C16284748780-1f386c64a-46d1-0266-e053-dadaa90a7c1aBlue Lizard Active SPF 50 Sunscreen
0316-2072-452023-01-30C16284748780-1f386c64a-46d1-0266-e053-dadaa90a7c1aBlue Lizard Active SPF 50 Sunscreen
0316-2072-502023-01-30C16284748780-1f386c64a-46d1-0266-e053-dadaa90a7c1aBlue Lizard Active SPF 50 Sunscreen

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-2072BLUE LIZARD ACTIVE SPF 50 SUNSCREEN (OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]5Legacy NDC20241127_6cd2936e-ded7-43a2-beea-9dfaf538176f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-20720316-2072-30, 0316-2072-50, 0316-2072-45, 0316-2072-40

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ALUMINUM OXIDELMI26O6933IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
YELLOW WAX2ZA36H0S2VIACT
ARGININE94ZLA3W45FIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
EDETATE DISODIUM7FLD91C86KIACT
CAPRYLYL GLYCOL00YIU5438UIACT
HEXYL LAURATE4CG9F9W01QIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
METHYL GLUCOSE DIOLEATEFA9KFJ4Z6PIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
PEG-7 HYDROGENATED CASTOR OILWE09129TH5IACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPANEDIOL5965N8W85TIACT
WATER059QF0KO0RIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONE92RU3N3Y1OIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)25LXE464L2IACT
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)AG75W62QYUIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENYLPROPANOL0F897O3O4MIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
POLYURETHANE-35 (NOT MORE THAN 500 MPA.S AT 40%)Q2LKX89BE0IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ISOSTEARYL ISOSTEARATEIV0Z586Z4YIACT
OCTISALATE4X49Y0596WACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
483477db-87e7-8445-e063-6294a90a44c06cd2936e-ded7-43a2-beea-9dfaf538176f2026-01-12WarningsExact identifier
spl set id: 6cd2936e-ded7-43a2-beea-9dfaf538176f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.